Abivax Sa · EURONEXT:ABVX
Abivax Sa — Investor Presentation (July 2026)
87 slides from Abivax Sa's investor presentation, July 2026
Slide 1: Corporate Presentation
Corporate Presentation July 2026
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains information pertaining to Abivax SA (“Abivax,” the “Company,” “we,” “our” or “us”). Certain statements included in this presentation that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the
Slide 3: Abivax Pipeline
Abivax Pipeline Drug Candidate Regimen Indication Research Preclinical Phase 1 Phase 2 Phase 3 FDA Filing Achieved & Anticipated Milestones ▪ Enrollment completed April 2025 Moderately to Severely Active Pivotal Phase 3 Program (ABTECT) ▪ Induction trial topline data Obefazimod Monotherapy readout o
Slide 4: Commercial Opportunity
Commercial Opportunity ABIVRX
Slide 5: WW IBD Sales Expected to Increase, with Significant Growth Anticipated in UC
WW IBD Sales Expected to Increase, with Significant Growth Anticipated in UC US and WW IBD annual sales forecasted to grow to ~$30B and ~$41B, respectively, by 20321 Evaluate Pharma US IBD Sales ($B)1 Evaluate Pharma Worldwide IBD Sales ($B)2 $41.2 B $29.9 B $19.4 B $24.4 B 30% $15.0 B $16.5 B $15.2
Slide 6: Obefazimod: Mega-Blockbuster Potential in US Alone Between UC and CD Indications
Obefazimod: Mega-Blockbuster Potential in US Alone Between UC and CD Indications Evolution of Obefazimod Target Patient Population Key Obefazimod Patient Populations in the US Secure Access Advance to 1L Expansion of Advanced 1L Expand into CD ~$7.5B Market ~$7.5B Market ~$15B Market 2L-3L+ 1L Advan
Slide 7: Conventional Line of Therapy
Approximately 80% of all first line patients remain on an anti-TNF or Entyvio Estimated Market Share by Line of Therapy in 20251 % of Patients by Line of Therapy Skyrizi – 23% Rinvoq – 29% ~50K patients 3rd Anti-IL-23 therapies have emerged + Anti-IL-23 JAKs Anti-TNFs Anti-Integrin S1Ps as the prefe
Slide 8: Mechanism of Action
Mechanism of Action ABIVRX
Slide 9: Obefazimod Development
Obefazimod Development An oral small molecule that enhances the expression of miR-124 Discovery Transition to Inflammation Clinical Development 2009 – 2015 2015 – 2017 2017 – Present Obefazimod Initial Development miR-124 MOA Evidence in Obefazimod Clinical Pre-Clinical POC Humans Trial Programs Dis
Slide 10: Obefazimod Restores Immune Balance in UC through Physiologic Immunoregulation
Obefazimod Restores Immune Balance in UC through Physiologic Immunoregulation Obefazimod MoA addresses multiple hallmarks of IBD pathology & chronic inflammation Active UC Obe ↑ miR-124 Obefazimod Restoring Balance Remission Th17 Cell 1 Gut Lumen Gut Lumen Th17 cells Epithelium Epithelium Lamina IL-
Slide 11: Obefazimod was associated with enhanced expression of miR-124
Obefazimod was associated with enhanced expression of miR-124 miR-124 expression in blood and colon tissues from Phase 3 induction trials miR-124 Expression in Blood at Week 8 miR-124 Expression Colon Tissues at Week 8 in Patients With UC in Patients With UC MiR-124 in Blood (PBMCs) MiR-124 in Recta
Slide 12: Obefazimod was also associated with reductions in proinflammatory cytokines
Obefazimod was also associated with reductions in proinflammatory cytokines IL-17A and IL-6 IL-17A Changes from Baseline to Week 8 in Serum from Patients with UC: IL-6 Changes from Baseline to Week 8 in Serum from Patients with UC: ABTECT 1 and ABTECT 2 Trials ABTECT 1 and ABTECT 2 Trials IL-17A IL-
Slide 13: Strength of obefazimod Method of Use Patent Rigorously Assessed and Confirmed
Strength of obefazimod Method of Use Patent Rigorously Assessed and Confirmed by Two Globally Renowned IP Law Firms Patent Extension Timeline 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 Granted Patent Product: Compound Composition of matter (product clai
Slide 14: Phase 3 Topline Data Readout
Phase 3 Topline Data Readout 14
Slide 15: ABTECT Phase 3 Program in Ulcerative Colitis Induction Trials and Maintenance Trial
Induction ABTECT Phase 3 Program in Ulcerative Colitis 2 Induction Trials and 1 Maintenance Trial Screening Induction Trials Maintenance Trial ❑ Moderately to severely Assessment at Week 52 ABTECT 1 Obe 50 mg (n=318) Long-Term Randomization active UC defined by: Obe 50 mg Randomization ABX464- Exten
Slide 16: Baseline Characteristics: Generally Well Balanced
Induction Baseline Characteristics: Generally Well Balanced Slightly more severe and refractory population randomized to 25mg group in ABTECT 2 vs. ABTECT 1 Pooled ABTECT 1 & 2 ABTECT 1 (105) ABTECT 2 (106) Placebo Obe 25 mg Obe 50 mg Placebo Obe 25 mg Obe 50 mg Placebo Obe 25 mg Obe 50 mg (N=317) (
Slide 17: Obefazimod Met the FDA Primary Endpoint with Both Doses in a Pooled Analysis
Induction Obefazimod Met the FDA Primary Endpoint with Both Doses in a Pooled Analysis 50mg exceeded previous Phase 2b results; 25mg results were comparable to Phase 2b* Pooled Clinical Remission – ABTECT 1 & ABTECT 2 ∆ 16.4%a % of Patients Achieving Endpoint p<0.0001c ∆ 13.2%a p<0.0001c 20.8% 17.6%
Slide 18: Obefazimod Achieved Statistical Significance with Both Doses in ABTECT 1
Induction Obefazimod Achieved Statistical Significance with Both Doses in ABTECT 1 25mg and 50mg both statistically significant and clinically meaningful in all key secondary endpoints Clinical Remission – ABTECT 1 (105) FDA Key Secondary Endpoints – ABTECT 1 (105) ∆ 32.6%a FDA Primary Endpoint p<0.
Slide 19: Obefazimod Met the FDA Primary Endpoint with 50mg in ABTECT 2
Induction Obefazimod Met the FDA Primary Endpoint with 50mg in ABTECT 2 50mg achieved statistical significance on all key secondary endpoints in ABTECT 2 Clinical Remission – ABTECT 2 (106) FDA Key Secondary Endpoints – ABTECT 2 (106) ∆ 29.6%a FDA Primary Endpoint p<0.0001 ∆ 20.1%a ∆ 25.4%a p=0.0002
Slide 20: Pooled ABTECT 1 & 2: Improvements in all Clinical Endpoints Regardless of Prior AT-IR
Induction Pooled ABTECT 1 & 2: 50mg Dose Achieved Clinically Meaningful Improvements in all Clinical Endpoints Regardless of Prior AT-IR 25mg and 50mg perform similarly in subgroup with no prior AT-IR in pooled data set AT-IR Yes AT-IR No ∆ 28%b p<0.0001 ∆ 19%b ∆ 31%b ∆ 35%b p<0.0001 p<0.0001 p<0.00
Slide 21: Clinical Response by Number of Prior AT Inadequate Responses and Prior JAK Inhibitor
Induction Clinical Response by Number of Prior AT Inadequate Responses and Prior JAK Inhibitor 50mg clinical response consistent in subgroups with no prior AT-IR through 4+ AT-IR or JAK-IR Pooled Clinical Responseb by Number of Prior Advanced Therapy (AT) Inadequate Response Pooled Clinical ∆ 28%a R
Slide 22: Safety Summary – ABTECT 1 & 2 – Pooled Full Data Set
Induction Safety Summary – ABTECT 1 & 2 ─ Pooled Full Data Set ABTECT 1 & 2 – Pooled Full Data Set Placebo Obefazimod 25 mg Obefazimod 50 mg Treatment Emergent Adverse Events (TEAE), n (%) (N=317) (N=319) (N=636) Any TEAE 161 (50.8) 156 (48.9) 383 (60.2) TEAE leading to study drug discontinuation 15
Slide 23: ABTECT Maintenance – Part 1
ABTECT Maintenance – Part 1 23
Slide 24: ABTECT Maintenance Phase 3 Trial Design
ABTECT Maintenance Part 1 ABTECT Phase 3 Responder Re-Randomized Maintenance Trial Design ABTECT Clinical Trial Design Induction Trials Maintenance Trial 8 Weeks 44 Weeks Primary Endpoint: Primary Endpoint: Clinical Remission Clinical Remission Placebo (n=192) Assessment at Week 52 Assessment at Wee
Slide 25: ABTECT Maintenance Phase 3 Baseline Characteristics and Completion Rate
ABTECT Maintenance Part 1 ABTECT Maintenance Phase 3 Baseline Characteristics and Completion Rate Placebo Obe 25 mg Obe 50 mg Study Participants 192 193 195 Age (Years), Mean (SD) 41.3 (13.4) 43.0 (13.7) 42.3 (14.4) Baseline Induction MMS, 6.9 (1.1) 6.7 (1.1) 6.9 (1.2) Mean (SD) Duration of Disease
Slide 26: Obefazimod 25 mg & 50 mg delivered statistically significant, clinically meaningful efficacy
ABTECT Maintenance Part 1 Obefazimod 25 mg & 50 mg delivered statistically significant, clinically meaningful efficacy results, with placebo-adjusted remission of ∆39.3% and ∆40.3%, respectively ABTECT Maintenance – Primary Endpoint ∆ 40.3%a p<0.0001 ∆ 39.3%a % of Patients Achieving Endpoint p<0.000
Slide 27: Obefazimod achieved statistical significance on all key secondary endpoints
ABTECT Maintenance Part 1 Obefazimod achieved statistical significance on all key secondary endpoints ABTECT Maintenance – Key Secondary Endpoints ∆ 49.1%a ∆ 51.0%a p<0.0001 p<0.0001 ∆ 46.5%a ∆ 52.8%a % of Patients Achieving Endpoint p<0.0001 p<0.0001 ∆ 37.8%a ∆ 38.0%a ∆ 42.5%a ∆ 39.4%a 67.1% 65.6%
Slide 28: Safety Results Summary – ABTECT Maintenance Part 1
ABTECT Maintenance Part 1 Safety Results Summary – ABTECT Maintenance Part 1 ABTECT Maintenance Part 1 Placebo Obe 25 mg Obe 50 mg Summary Safety Events, n (%) (N=192) (N=193) (N=195) Any TEAE 96 (50.0%) 112 (58.0%) 140 (71.8%) TEAE leading to study drug discontinuation 13 (6.8%) 5 (2.6%) 9 (4.6%) S
Slide 29: Clinical Remission Maintenance Data
ABTECT Maintenance Part 1 Clinical Remission Maintenance Data Obefazimod 50 mg and 25 mg delivered the highest placebo-adjusted clinical remission reported to date Obe Ph3 Maintenance Efficacy of FDA/EMA Approved UC Products: Clinical Remission* at 52 Weeks Induction Responders Induction Responders
Slide 30: Endoscopic Remission Maintenance Data
ABTECT Maintenance Part 1 Endoscopic Remission Maintenance Data Obefazimod 50 mg and 25 mg delivered potential best-in-disease endoscopic remission reported to date Obe Ph3 Maintenance Efficacy of FDA/EMA Approved UC Products: Endoscopic Remission* at 52 Weeks Induction Responders Induction Responde
Slide 31: ABTECT Maintenance – Part 2
ABTECT Maintenance – Part 2 31
Slide 32: Part 2 Study Design: Difficult-to-Treat Population
ABTECT Maintenance Part 2 Part 2 Study Design: Difficult-to-Treat Population Part 1 Relapsers and Induction Non-Responders 1 2 3 4 Part 2 serves as a Part 2 includes two distinct Part 2 patients are more All patients receive obefazimod supplemental dataset to Part 1 patient populations refractory an
Slide 33: Part 2 Patients Entered Maintenance With A Greater Inflammatory Burden Than Part 1 Patients
ABTECT Maintenance Part 2 Part 2 Patients Entered Maintenance With A Greater Inflammatory Burden Than Part 1 Patients Baseline Characteristics at Start of Maintenance Post-Induction Focus of Today Part 1 Part 2 Induction Responders* Induction Non-responders (N=678) (N=437) Measure Maintenance Baseli
Slide 34: Continued Obefazimod Treatment Delivered Unprecedented Efficacy for Induction Non-Responders
ABTECT Maintenance Part 2 Continued Obefazimod Treatment Delivered Unprecedented Efficacy Results for Patients who Failed to Respond After 8 Weeks Part 2: Induction Non-Responders – Exploratory Efficacy Endpoints At Week 44 of Maintenance 25 mg: All remitters were steroid-free 50 mg: Only 4 of 55 re
Slide 35: Dose Escalation From 25 mg to 50 mg Restored Disease Control in Relapsers
ABTECT Maintenance Part 2 Dose Escalation From 25 mg to 50 mg Restored Disease Control in Patients Who Relapsed in Part 1, Supporting a Practical, Real-World Treatment Approach Part 1 Relapsers: Dose Escalation After Relapse on 25mg 25/50 mg (Induction) → 25 mg (Part 1) → Relapse → 50 mg (Part 2) N=
Slide 36: Obefazimod Achieved the Highest Endoscopic Remission Rate Among All UC Therapies
ABTECT Maintenance Part 2 Obefazimod Achieved the Highest Endoscopic Remission Rate Among All UC Therapies Obefazimod delivered transformational endoscopic remission, even in induction non-responders Obe Ph3 Obe Ph3 Maintenance Efficacy of FDA Approved UC Products: Endoscopic Remission* at 52 Weeks
Slide 37: Obe 50 mg Accounts for 49% of Patient Year Exposure in Integrated UC Clinical Program
ABTECT Maintenance Part 2 Obe 50 mg Accounts for 49% of Patient Year Exposure in Integrated UC Clinical Program Placebo accounts for a small minority of patient-year exposure Patient Years Overview for Exposure-Adjusted Incidence Rates Analysis Set Treatment Patient Exposure Distribution Arm Years I
Slide 38: Favorable Safety Profile Observed in Part 2, Consistent with Overall Safety Experience
ABTECT Maintenance Part 2 Favorable Safety Profile Observed in Part 2, Consistent with the Overall Obefazimod Safety Experience ABTECT Maintenance Part 2 Safety Results Obe 25 mg Obe 50 mg Summary Safety Events, n (%) N=186 N=447* Any TEAE 132 (71.0%) 307 (68.7%) TEAE leading to study drug discontin
Slide 39: Abivax Conducted Regulatory Assessments with Multiple Former FDA Senior Leaders
Regulatory Assessment Abivax Conducted Regulatory Assessments with Multiple Former FDA Senior Leaders Following the ABTECT Maintenance Part 1 and 2 Readouts Feedback from Four Regulatory Consultants Regarding Part 1 and 2 Data 1 Safety & Labeling 2 Dose Strategy 3 Totality of Evidence Strong support
Slide 40: Regulatory Filing Strategy: Pursue Both 25 mg and 50 mg Doses for Maintenance
Regulatory Assessment Regulatory Filing Strategy: Pursue Both 25 mg and 50 mg Doses for Maintenance Top Priority Induction Maintenance 8 weeks GOAL: File for BOTH 25 mg and 50 mg as 50 mg 25 mg 50 mg Flexible dosing could maintenance enable treatment Best-in-disease Best-in-disease optimization base
Slide 41: Obefazimod Demonstrates Best-in-Disease Opportunity for Ulcerative Colitis
Summary Obefazimod Demonstrates Best-in-Disease Opportunity for Ulcerative Colitis Differentiated value proposition supports blockbuster commercial opportunity Obefazimod demonstrated best-in-disease efficacy in both treatment-naïve and highly Best-In-Disease Efficacy refractory ulcerative colitis p
Slide 42: Obefazimod in Crohn's Disease – Phase 2b
Obefazimod in Crohn’s Disease – Phase 2b 42
Slide 43: Obefazimod MoA Addresses Multiple Mediators of Crohn's Disease Progression
Crohn’s Disease Obefazimod MoA Addresses Multiple Mediators of Crohn’s Disease Progression Modulation of Th17 cells, macrophages and fibroblasts attenuates inflammatory and fibrotic pathways Active CD Obe ↑ miR-124 Obefazimod Restoring Balance Remission Gut Lumen Gut Lumen 1 Th17 Cell Th17 cells IL-
Slide 44: Two well-established models were used to assess obefazimod's anti-fibrotic effects
Crohn’s Disease Two well-established models were used to assess obefazimod’s anti-fibrotic effects Model 1 Model 2 In Vitro Scar-in-a-Jar Assay In Vivo Chronic TNBS Colitis Mouse Model 1. Omipalisib (anti-fibrotic) 2. Upadacitinib (anti-inflammatory) 3. Obefazimod Scar-in-a-Jar is an in vitro assay
Slide 45: Model 1: Anti-fibrotic effect in scar-in-a-jar model
Crohn’s Disease Model 1: Obefazimod showed an anti-fibrotic effect on human small intestine fibroblasts in the scar-in-a-jar model Collagen Remodeling Fibroblast Activation (PRO-C3) (α-SMA) α-SMA Alpha-smooth muscle actin ✱✱✱✱ ✱✱✱✱ 15 20 ✱✱ ✱ ns 15 Fluorescence 490/530 Fluorescence 490/530 Results 1
Slide 46: Model 2: Reduced fibrosis in the chronic TNBS mouse model
Crohn’s Disease Model 2: Obefazimod led to reduced fibrosis in the chronic TNBS mouse model Collagen Deposition α-SMA Histologic Fibrosis Score (% positive area at day 35 – Sirius Red) (% positive area at day 35) (at day 35) Results: Day 35 (EtOH) Vehicle TNBS Day 20 Conclusions Obefazimod showed an
Slide 47: Obefazimod in Crohn's Disease: Mechanistic Rationale
Crohn’s Disease Obefazimod in Crohn’s Disease Mechanistic Rationale 1 Direct action on tissue-resident effectors 2 3 Attenuation of the IL-6/STAT3–Th17 axis Macrophage “De-Fueling” (Th17/macrophages) ▪ miR-124 upregulation in myeloid cells ▪ Obefazimod boosts miR-124 (via a CBC- ▪ IL-6/STAT3–Th17 ax
Slide 48: Phase 3 UC Induction Trials: Therapies That Later Failed in CD
Crohn’s Disease Phase 3 UC Induction Trials: Therapies That Later Failed in CD Generally, Did Not Achieve Placebo-Adjusted Endoscopic Improvement Above ~20% Placebo-Adjusted Endoscopic Improvement (%) in Phase 3 UC Induction Trials Filgotinib P3 SELECTION B 200 mg (UC) Velsipity P3 ELEVATE UC-2 2 mg
Slide 49: ENHANCE CD: Phase 2b Trial Design
Crohn’s Disease ENHANCE CD: Phase 2b Trial Design Obefazimod in Crohn’s Disease Total Study Duration: Up to 2 years Screening 12-Week Induction Phase 40-Week Maintenance Phase Up to 4 weeks Week 12 Week 52 Responders ❑ Moderately to severely active 50 mg (n=53) 50 mg Randomization CD as defined by:
Slide 50: Multiple MOAs are being assessed to identify combination therapy candidate
Combo Therapy Multiple MOAs are being assessed to identify candidate that will have the greatest synergistic effect with obefazimod, without compromising on safety Criteria For Combination Therapy Candidate Synergistic Pathways Safe Oral ▪ No pre-initiation requirements ▪ Enable broader disease cont
Slide 51: Upcoming Catalysts
51 Upcoming Catalysts ABIVRX
Slide 52: Key Milestones Through Mid-2027
Key Milestones Through Mid-2027 Q3 2025 Phase 3 Topline UC Induction Data Late Q2, 2026 Phase 3 Topline UC Maintenance Data Late 2026 Expected Obefazimod US FDA NDA Submission Year end 2026 IBD Combo Therapy Candidate Selection Mid-2027 Phase 2b Topline CD Induction Data 2025 2026 2027 Q3 Q4 Q1 Q2 Q
Slide 53: Thank You
Thank You Nasdaq: ABVX / Euronext Paris: ABVX 53
Slide 54: Appendix
Appendix ABIVRX
Slide 55: Clinical Remission Induction Data of FDA/EMA Approved UC Products
Induction Clinical Remission Induction Data of FDA/EMA Approved UC Products Clinical Remission Induction Efficacy2 of FDA/EMA Approved UC Products: 6-12 Weeks Biologics Orals ∆ 12% ∆ 12% ∆ 10% ∆ 16% ∆ 15% ∆ 10% ∆ 13% ∆ 11% ∆ 8% ∆ 21% ∆ 29% ∆ 12% ∆ 11% ∆ 20% 40% 35% 33% 30% 27% 26% 26% 26% Subjects (
Slide 56: Improvements in Endoscopic & Histologic Endpoints Regardless of Prior AT-IR
Induction Pooled ABTECT 1 & 2: 50mg Dose Achieved Clinically Meaningful Improvements in Endoscopic & Histologic Endpoints Regardless of Prior AT-IR 50mg outperformed 25mg in subjects with prior AT-IR; 25mg and 50mg performed similarly with no prior AT-IR AT-IR Yes AT-IR No ∆ 35%b p<0.0001 ∆ 35%b ∆ 2
Slide 57: Rates of symptomatic remission across subgroups of AT-IR patients
Induction Rates of symptomatic remission across subgroups of AT-IR patients Danese S et al. P0894. Poster presented at: the 21st Congress of ECCO, February 18–21, 2026, Stockholm, Sweden Analyses not powered for statistical significance in small subgroups; results are exploratory and directional. No
Slide 58: Symptomatic response and remission over time through Week 8
Induction Greater proportions of patients receiving obefazimod achieved symptomatic response from W1 and symptomatic remission from W2 increasing through W8 with no evidence of a plateau Proportion of Patients Achieving Symptomatic Response, Symptomatic Remission Pooled ABTECT-1 and ABTECT-2 Studies
Slide 59: Malignancy Exposure-Adjusted Incidence Rate Summary Tables
Malignancies Excluding NMSCs Malignancy Exposure-Adjusted Incidence Rate Summary Tables Phase 3 Maintenance Integrated UC Clinical Program (Phase 3 + Phase 2) Maintenance Placebo 25 mg 50 mg All Active Expected UC Phase 3 (Ind, Part 1 & 2) Placebo 25 mg 50 mg All Active Expected UC (Part 2 Only) Com
Slide 60: NMSC Exposure-Adjusted Incidence Rate Summary Tables
NMSCs NMSC Exposure-Adjusted Incidence Rate Summary Tables Phase 3 Maintenance Integrated UC Clinical Program (Phase 3 + Phase 2) Maintenance Placebo 25 mg 50 mg All Active Expected UC Phase 3 (Ind, Part 1 & 2) Placebo 25 mg 50 mg All Active Expected UC (Part 2 Only) Combined Background + Phase 2 Pr
Slide 61: NMSC Rates Consistent with Reference Range Across All Three Datasets
ABTECT Maintenance Part 2 NMSCs All Active Combined NMSC Rates Were Consistent With the Reference Range Across All Three Datasets Integrated UC Clinical Program Reference Range All Active (Phase 2 + Phase 3 Induction Placebo 25 mg 50 mg Based on Published Combined and Maintenance) UC Studies Increas
Slide 62: Malignancy Rates Consistent with Reference Range Across All Three Datasets
ABTECT Maintenance Part 2 Malignancies Excluding NMSCs All Active Combined Malignancy Other Than NMSC Rates were Consistent with the Reference Range Across All Three Datasets Integrated UC Clinical Program Reference Range All Active (Phase 2 + Phase 3 Induction Placebo 25 mg 50 mg Based on Published
Slide 63: Treatment-Emergent Adverse Events (≥1% and greater than placebo)
Induction Treatment-Emergent Adverse Events (≥1% and greater than placebo) ABTECT 1 & 2 – Pooled Full Data Set Placebo Obefazimod 25 mg Obefazimod 50 mg (N=317) (N=319) (N=636) Headache* 19 (6.0) 51 (16.0) 153 (24.1) Headache leading to study discontinuation (per subject), n (%) 0 1 (0.3) 7 (1.1) Ti
Slide 64: No clustering of serious TEAEs was observed
Induction No clustering of serious TEAEs was observed; only worsening of UC and pneumonia were reported more than once in any individual treatment arm Serious TEAEs in ABTECT Induction Trials Obe-50 Obe-25 PBO (n=636) (n=319) (n=317) Serious TEAE, n (%) 20 (3.1) 7 (2.2) 10 (3.2) Colitis ulcerative 5
Slide 65: ABTECT 1&2: Obefazimod 50mg Achieves Endoscopic Remission by Week 8
ABTECT 1&2: Obefazimod 50mg Achieves Endoscopic Remission by Week 8 In ABTECT 1 both 25mg and 50mg achieved endoscopic remission Endoscopic Remission – ABTECT 1 Endoscopic Remission – ABTECT 2 ∆ 14%a ∆ 13%a % of Patients Achieving Endpoint % of Patients Achieving Endpoint p<0.0001c p<0.0001c ∆ 19%a
Slide 66: Over 55% of Part 2 Participants Previously Failed 1 or More Advanced Therapies
ABTECT Maintenance Part 2 Over 55% of Part 2 Participants Previously Failed 1 or More Advanced Therapies Comparing Maintenance Part 1 and Part 2 Patient Populations Part 1 Part 2 Induction Responders – Part 1 Induction Non-Responders‡ – Part 2 Part 1 Relapsers* – Switch to Part 2 Double-Blind Placeb
Slide 67: Two Malignancies Excluding NMSCs Observed in Part 2 Maintenance Trial
ABTECT Maintenance Part 2 Malignancies Excluding NMSCs Two Malignancies Excluding NMSCs Observed in Part 2 Maintenance Trial Multiple confounding pre-existing risk factors for both malignancy cases Part 2 Malignancy Cases in Context Obefazimod 25 mg Obefazimod 50 mg Total in Part 2 Preferred Term N=
Slide 68: Nonclinical Photosensitivity Finding Led to Enhanced Skin Surveillance
A Nonclinical Photosensitivity Finding Led to Enhanced Skin Surveillance in the ABTECT Phase 3 and Phase 2 OLE Protocols Photosensitivity in Context Rigorous Skin Lesion Monitoring in Skin Lesion: No difference between Nonclinical Photosensitivity Findings ABTECT and Phase 2 OLE obefazimod and place
Slide 69: No Increase in Skin Lesion Occurrence Between Placebo and Obefazimod
No Increase in Skin Lesion Occurrence Between Placebo and Obefazimod Despite Robust Surveillance Skin Lesion Summary – Phase 3 Maintenance Program Maintenance Part 1 & Part 2 Combined Patient Years of Exposure ~147 ~274 ~438 Placebo Obe 25 mg Obe 50 mg n (IR per 100 PY) n (IR per 100 PY) N (IR per 1
Slide 70: All Four Part 2 NMSC Cases Occurred in Patients with Established Risk Factors
ABTECT Maintenance Part 2 NMSCs All Four Part 2 NMSC Cases Occurred in Patients with Established NMSC Risk Factors Advanced age (3/4), thiopurine use (3/4), prior skin cancer history (2/4), failure of multiple advanced therapies (3/4) Part 2 NMSC Cases in Context Obefazimod 25 mg Obefazimod 50 mg To
Slide 71: Safety Database Now Includes >1,700 Patient-Years of Exposure
ABTECT Maintenance Part 2 Safety Database Now Includes >1,700 Patient-Years of Exposure Key safety observations from the expanded maintenance dataset Safety Analysis Summary Favorable Safety With the addition of Part 2 maintenance data, the obefazimod safety database now includes >1,700 1 Profile Ma
Slide 72: Additional Efficacy
72 ADDITIONAL EFFICACY ABIVRX
Slide 73: Obefazimod Recaptured Response in Patients who Relapsed After Placebo
Obefazimod Also Recaptured Response in Patients who Relapsed After Being Randomized to Placebo in Part 1 and Switched to 50 mg in Part 2 Part 1 Relapsers: Relapse After Treatment Interruption 25/50 mg (Induction) → Placebo (Part 1) → Relapse →50 mg (Part 2) N=109, Week 44 of Maintenance 69.7% 54.1%
Slide 74: Phase 3 Induction and Phase 3 Part 2 Patient Cases
PHASE 3 INDUCTION AND PHASE 3 PART 2 PATIENT CASES 74
Slide 75: Malignancy in Phase 3 Induction
Malignancies Excluding NMSCs Malignancy in Phase 3 Induction Months of Medical Gender/ Obefazimod Treatment Investigator Preferred Term Obe Location Prior UC Treatment History of Medical History & Summary Age Duration Assessment* Exposure Cancer Prostatic hyperplasia (benign prostatic hyperplasia) t
Slide 76: Part 2: Malignancies other than non-melanoma skin cancers
Malignancies Excluding NMSCs Part 2: Malignancies other than non-melanoma skin cancers (non-NMSC) Medical Gender/ Obefazimod Treatment Months of Investigator Preferred Term Location Prior UC Treatment History of Medical History & Summary Age Duration Obe Exposure Assessment* Cancer MH of thrombocyth
Slide 77: All four Part 2 NMSC cases occurred in patients with established NMSC risk factors
NMSCs All four Part 2 NMSC cases occurred in patients with established NMSC risk factors Advanced age (3/4), thiopurine use (3/4), prior skin cancer history (2/4), failure of multiple advanced therapies (3/4) Medical Gender/ Obefazimod Treatment Months of Investigator Preferred Term Location Prior U
Slide 78: Reported Part 2 acute pancreatitis events and clinical context
Reported Part 2 acute pancreatitis events occurred in patients with medical history and relevant clinical context Case 1: 25 mg Case 2: 50 mg Age: 50+ Location: Central Europe Age: 35+ Location: Eastern Europe Induction: PBO (8 wks) Treatment duration: Induction: 50 mg (8 wks) Treatment duration: Ma
Slide 79: Deaths Reported in Competitor Phase 3 Trials for Context
Deaths Reported in Competitor Phase 3 Trials for Context Obefazimod: One Non-Treatment Related Death in ABTECT Maintenance Part 2 Phase 3 UC Program Drug (Brand) (Induction + Maintenance) Details of Non-Treatment Related Death in ABTECT Part 2 Active Drug – 52 weeks Death (n) Treatment Arm 25 mg Age
Slide 80: Phase 2 Patient Years and Cases
PHASE 2 PATIENT YEARS AND CASES 80
Slide 81: Long-term Phase 2 experience included ~858 patient years of exposure
Phase 2 Long-term Phase 2 experience included ~858 patient years of exposure TOTAL PHASE 2 PATIENT YEARS (PYs)* ~858 PY of Obe Exposure 50 mg = ~404 PY, 25 mg = ~434 PY, PBO = ~20PY MH = Medical History; Patient Years for this analysis included obefazimod exposure only; *As of May 2026 81 Data on Fi
Slide 82: Malignancy / NMSC in Phase 2 Studies
Malignancies Excluding NMSCs NMSCs Malignancy / NMSC in Phase 2 Studies Medical Gender/ Obefazimod Treatment Months of Investigator Preferred Term Location Prior UC Treatment History of Medical History & Summary Age Duration Obe Exposure Assessment* Cancer Approximately 14 months after treatment ini
Slide 83: Protocol
83 PROTOCOL ABIVRX
Slide 84: Enhanced skin lesion surveillance protocol following photosensitivity findings
ABTECT Phase 3 and Phase 2b OLE protocols incorporated enhanced skin lesion surveillance following pre-clinical photosensitivity findings Initial Protocol ABX464-108 CSP, v1.0, released 01-Sep-2021 Obefazimod Initial Obefazimod Updated Protocol Feature (ABX-484-108 v1.0) (ABTECT/108 v3.0) Skin lesio
Slide 85: Incidence Rates Calculations
INCIDENCE RATES CALCULATIONS 85
Slide 86: How Malignancy Incidence Rates (per 100 Patient-Years) Were Derived
Malignancies Excluding NMSCs How Malignancy Incidence Rates (per 100 Patient-Years) Were Derived 1 Published Sources 2 Converted to 100 Patient Years 3 Derived Benchmark Range ▪ Long MD, Martin CF, Pipkin CA, et al. Risk of melanoma and nonmelanoma skin cancer among patients with inflammatory bowel
Slide 87: How NMSC Incidence Rates (per 100 Patient-Years) Were Derived
NMSCs How NMSC Incidence Rates (per 100 Patient-Years) Were Derived 1 Published Sources 2 Converted to 100 Patient Years 3 Derived Benchmark Range NMSC Incidence (as Incidence Published NMSC incidence in IBD/UC Source Population Calculation population is generally on the order of: reported) (per 100